Are you a life sciences graduate looking for an exciting career opportunity in clinical research? Parexel, a leading global biopharmaceutical services organization, is currently hiring for the position of Clinical Research Associate II (CRA II) in Bengaluru. If you hold a degree in B.Sc, M.Sc, B.Pharm, or M.Pharm and have a passion for clinical trials, this could be the perfect role for you. Read on to learn more about this opportunity and how to apply.
Job Overview
As a Clinical Research Associate II (CRA II) at Parexel, you will play a pivotal role in managing and overseeing clinical trial sites from start-up through close-out. This position offers the chance to work with leading investigators and site staff, ensuring the highest standards of quality and compliance in clinical research.
Key Responsibilities
Start-Up Phase
- Act as Parexel’s primary point of contact for assigned sites, ensuring quality and timely delivery during the start-up phase.
- Build and maintain strong relationships with investigators and site staff.
- Conduct and manage country-specific feasibility and site qualification activities, including Confidentiality Agreements (CDAs) and Clinical Site Agreements (CSAs).
- Perform remote Qualification Visits (QVs) and generate detailed visit/contact reports.
- Develop and manage strategies for IRB/IEC and MoH/RA submissions, site activation, and patient recruitment.
- Customize and negotiate Informed Consent Forms (ICFs) and ensure compliance with regulatory requirements.
- Maintain accurate and up-to-date records in Clinical Trial Management Systems (CTMS).
Maintenance Phase
- Monitor and ensure the integrity of study implementation and protocol adherence at clinical sites.
- Address and resolve site-related issues, including training needs, documentation deficiencies, and communication gaps.
- Conduct on-site visits, including Qualification and Initiation Visits, and provide study-specific training as needed.
- Evaluate site performance, recruitment plans, and compliance, recommending improvements where necessary.
- Manage study supplies, site payments, and follow-up on CRF data entry and query resolution.
- Participate in Investigator meetings, audits, and regulatory inspections as required.
Qualifications and Skills
- Educational Background: B.Sc, M.Sc, B.Pharm, or M.Pharm in life sciences or a related field.
- Experience: Prior experience in clinical research or site management is preferred.
- Skills: Strong organizational, communication, and problem-solving skills. Ability to work independently and manage multiple tasks effectively.
- Knowledge: Familiarity with clinical trial protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
Why Join Parexel?
Parexel is a trusted partner in the biopharmaceutical industry, offering a collaborative and innovative work environment. By joining Parexel, you will have the opportunity to work on cutting-edge clinical trials, contribute to the development of life-saving therapies, and grow your career in clinical research.